BioCentury | Nov 25, 2020
Regulation

FDA says WHO study does not refute efficacy of Veklury for COVID-19

FDA on Wednesday made public the review that led to approval of Gilead’s Veklury remdesivir for treatment of hospitalized COVID-19 patients, and explained why it believes the WHO-sponsored SOLIDARITY trial that failed to demonstrate a...
BioCentury | Nov 21, 2020
Product Development

Nov. 20 Quick Takes: uniQure hemophilia therapy hits pivotal endpoint; plus data from Gilead in HIV, Aivita  in GBM and a setback for Poxel

uniQure hemophilia therapy hits co-primary Phase III endpointuniQure N.V. (NASDAQ:QURE) said gene therapy etranacogene dezaparvovec met one primary endpoint of the Phase III HOPE-B trial to treat hemophilia B. The adeno-associated viral serotype 5 (AAV5)...
BioCentury | Nov 21, 2020
Politics, Policy & Law

Fate of Trump’s 11th hour drug price rules uncertain

If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administration Friday...
BioCentury | Nov 20, 2020
Regulation

WHO counters FDA as it recommends against Veklury for COVID-19

The WHO’s new guidance counters FDA’s October approval of Gilead’s Veklury for hospitalized patients, adding to the debate around the drug’s use and variable performance in randomized, controlled trials. In The BMJ on Thursday, the WHO issued a...
BioCentury | Nov 20, 2020
Deals

China in-licensing play LianBio follows $310M crossover round with broad Pfizer deal

Pfizer’s deal with LianBio will provide the Perceptive-backed, cross-border start-up with a commercial infrastructure in China, while giving the pharma a drug hunter and development partner led by veteran China biotech executives Bing Li and Debra...
BioCentury | Nov 17, 2020
Regulation

FDA to post data on COVID-19 therapeutic, vaccine EUAs

Responding to public criticism of some of its COVID-19 emergency use authorization decisions, as well as a recommendation from a government watchdog agency, FDA announced Tuesday that it will...
BioCentury | Nov 17, 2020
Regulation

Another U-turn for COVID-19 testing regulation as HHS requires FDA to re-prioritize LDT review

The latest switchback in the U.S.’s regulation of COVID-19 tests sees HHS requiring FDA to review tests it previously said the agency lacked authority over, highlighting the challenge of pursuing a deregulatory agenda in the midst...
BioCentury | Nov 14, 2020
Product Development

Complete response for Sanofi’s rare anemia candidate; plus Sumitovant-Urovant, C4-Roche, IN8bio and Synendos

Setback for Sanofi rare anemia therapySanofi (Euronext:SAN; NASDAQ:SNY) said late Friday that FDA issued a complete response letter to a BLA for anti-C1s mAb sutimlimab to treat hemolysis in adults with cold agglutinin disease, a rare anemia....
BioCentury | Nov 14, 2020
Regulation

BioMarin withdraws MAA for hemophilia gene therapy following safety, durability concerns

Among CHMP’s monthly roundup of opinions was an MAA withdrawal for BioMarin’s hemophilia gene therapy linked to EMA concerns about safety and durability — issues that FDA raised in August. EMA said...
BioCentury | Nov 14, 2020
Deals

Innovation in a hurry: China biotechs see a fast track to global stage – survey

The Chinese biopharma landscape in five years will see a majority of the money magnet companies commanding innovation, with first-in-class targets filling their pipelines and innovative biologics outpacing...
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